MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL W/TWINPAK DEVICE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303393
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a large box was received.The box contained a loose 10ml twinpak syringe half-filled with clear medication in a zip lock bag, one used medication vial with some medication in it and labeled ¿tenecteplase,¿ and one empty small packaging kit that listed the above two items in it.Since the samples were contaminated on arrival, they were evaluated visually through the bags only.The syringe was observed to have a hub of the red syringe filling device (sfd) attached.There was no cannula present in the syringe filling device (sfd).It appeared to have been sheared off from the hub as evidenced by deformations at the tip of the hub.The vial had multiple piercing marks where it was punctured by a needle.No cannula was observed in the vial, syringe, nor any bags received.It is possible there was an issue with cannula lubrication or damage to the syringe filling device(sfd), as it is also possible that user error while using the device contributed to the failure.Based on the samples received, it was not possible to determine what may have happened to the syringe filling device's (sfd) cannula.Part of the syringe filling device(sfd) was missing from the samples received which could have provided a missing clue.There were also no unused packaged samples from the same lot received for evaluation of any potential issues.Since root cause could not be determined, corrective actions are not necessary.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the syringe 10ml ll w/twinpak device hub would not detach from the vial of tnkase and the needle broke off.The following information was provided by the initial reporter: "the reporter stated that in the process of drawing up the dose of tnkase (tenecteplase) on 03/29/2021, the red hub would not detach from the vial and the needle broke off.The reporter states the tnkase was drawn up with another needle and there was a slight delay in administration of 20 mins but it was given within the time frame of 60 mins." "the drug administration procedure was delayed for 20 mins in an emergency setting.Tnkase is used in emergency situations for use in the reduction of mortality associated with acute myocardial infarction (ami).Treatment should be initiated as soon as possible after the onset of ami symptoms.".

• Brand Name: SYRINGE 10ML LL W/TWINPAK DEVICE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11742482
• Report Number: 1213809-2021-00274
• Device Sequence Number: 19924785
• Product Code: FMI
• UDI-Device Identifier: 30382903033936
• UDI-Public: 30382903033936
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2024
• Device Model Number: 303393
• Device Catalogue Number: 303393
• Device Lot Number: 9323515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1